Trial Information

This is an open-label, single-center, non-randomized, single-arm, pilot imaging study to
determine the pharmacokinetics, biodistribution, and tumor targeting of an indium-111
(111In)-labeled, humanized anti-MUC1 antibody, designated hPAM4 IgG1 in patients with known
pancreatic cancer. The primary objective of this trial is to examine how changing the
protein dose will affect these parameters with the intent to determine if a single protein
dose can be selected to optimize tumor targeting. It is expected that these data will aid
in the selection of an appropriate protein dose to be used in a Phase I therapy trial with
yttrium-90 (90Y)-labeled hPAM4 IgG. The secondary objective is to monitor safety.

Pharmacokinetics, biodistribution, tumor targeting, and dosimetry (modeling for 90Y) will be
assessed against clinical parameters, such as pre-study PAM4-reactive MUC-1 antigen in the
serum, tumor size, location, histopathology, immunohistology, and if possible, antigen
content by extraction of tumor sample.

Inclusion Criteria:

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- All patients must either have a histologic or cytological diagnosis of pancreatic
cancer or a high clinical suspicion of pancreatic cancer.

- Patients must be 21 years of age.

- Patients must have measurable disease by CT scan.

- Patients must be at least 4 weeks beyond any major surgery.

- Patients must be at least 4 weeks beyond any chemotherapy or radiation therapy and
must have recovered from treatment-induced toxicity.

- Patients must have a performance status of 70% or greater on the Karnofsky Scale and
a minimal life expectancy of 3 months.

- Patients must not have severe anorexia, nausea or vomiting, and no signs of
intestinal obstruction.

- Patients must have a serum creatinine that is < 1.5 x the Institutional Upper Limit
of Normal (IULN).

- Patients must sign an informed consent, and be mentally responsible. There will be
no discrimination based on race, creed, or ethnic background.

- Patients must be able to return to an approved study site for the scheduled follow-up
procedures.

Exclusion Criteria:

A.Subjects with a significant concurrent medical complication that in the judgment of the
Principal Investigator could affect the patient's ability to tolerate or complete this
study. These include, but are not restricted to

Completion Date:

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